Clinical Trial

A Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome

Name: A Study of NNZ-2591 in Pediatric Participants With Phelan-McDermid Syndrome — clinical trial record (NCT07281079)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Recruiting Phase 3

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Summary

This Phase 3, randomized, double-blind, parallel-group (2-arm), placebo-controlled, multicenter study will evaluate the efficacy and safety of NNZ-2591 compared to placebo in pediatric participants with Phelan- McDermid Syndrome.

Protocol Amendment History 1 change

notable Trial sites expanded: 9 -> 12 locations 2026-07-08

Trial Details

NCT Number	NCT07281079
Lead Sponsor	Neuren Pharmaceuticals Limited
Conditions	Phelan-McDermid Syndrome
Enrollment	160 participants
Start Date	2025-11-12
Primary Completion	2027-10-31 (estimated)
Study Completion	2027-11-15 (estimated)
Updated on ClinicalTrials.gov	2026-08-12